# K243092: AcuPebble Ox (200)

- Pathway: 510(k) (Traditional)
- Applicant: Acurable Limited
- Decided: Mar 19, 2025 after 170 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002135 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222950: AcuPebble OX100, Acurable Limited (2023) Summary page 6.

## Indications for use
AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA).The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

Source page: https://510kreport.com/device/K243092
Methodology: https://510kreport.com/methodology